東方生物(688298.SH):新型冠狀病毒抗原自測試劑獲得加拿大IO臨時授權指定供應
格隆匯4月5日丨東方生物(688298.SH)公佈,公司的客户西門子醫療的“CLINITEST”新型冠狀病毒抗原自測試劑,於近日取得加拿大衞生部批准的加拿大IO臨時使用授權,公司本次作為西門子醫療該抗原自測產品的指定授權供應商。本產品獲得加拿大IO後,可在加拿大認定的國家緊急衞生事件應急期間,在加拿大及認可加拿大IO的國家/地區銷售。
本產品適用於直接從前鼻腔拭子樣本中定性檢測COVID-19抗原,是一款適用於非處方的家庭自測產品。
公司本次新冠病毒抗原自測試劑在取得歐盟CE認證、美國FDAEUA准入、中國NMPA認證、日本PMDA銷售許可、沙特MDMA認證及對應市場銷售的基礎上,新增加拿大IO指定供應,有利於公司進一步拓展國際市場,服務全球新冠病毒防疫需求。
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